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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
November 19, 1996 until December 20, 1996.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Reliability of original study is 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Results of guinea pig maximisation test were available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal induction with 0.5 % test substance
percutaneous induction with a 50 % test substance preparation
Challenge
Route:
other: percutaneous induction.
Vehicle:
water
No. of animals per dose:
The study was performed on 20 guinea pigs in the test group and 10 animais in each of control groups 1 and 2.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
test substance 25% in aqua bidest.
No. with + reactions:
5
Total no. in group:
19
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
test substance 25% in aqua bidest.
No. with + reactions:
3
Total no. in group:
18

Any other information on results incl. tables

The number of animais with skin findings after the ist challenge and after the 2nd challenge is summarized in the following table:

 

1st challenge

2st challenge

test substance 25% in aqua bidest.

test substance 25% in aqua bidest.

After 24 hours

After 48 hours

After 24 hours

After 48 hours

Control group 1

0/10

0/10

0/10

0/10

Control group 2**

no application of test substance

0/7

0/7

Test group**

5/19

3/18

0/17

0/17

x/y: number of positive reactions/number of animais tested (reading at 24 h and/or 48 h after the removal of the patch)

**: 3 test group animais and 3 animais of control group 2 died 18, 21, 22, 23 or 25 days after the beginning of the study. Macroscopic examination revealed that the cause of death was not substance related.

Applicant's summary and conclusion

Interpretation of results:
other: not classified as a skin sensitiser according to the CLP Regulation (EC) No.1272/2008
Conclusions:
not a skin sensitiser
Executive summary:

The substance was tested for its sensitizing effect an the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman. The intradermal induction with 0.5 % test substance preparations caused slight to well-defined signs of 5km irritation or necrotic skin changes in test group animais. After the percutaneous induction with a 50 % test substance preparation incrustation, partially open (caused by the intradermal induction; could be observed in addition to well-defined erythema and slight edemna or necrotic skin changes (caused by the * intradermal induction) and slight edema in test group animais. Two challenges were performed 14 and 21 days after the percutaneous induction.

After the first challenge with a 25 % test substance preparation very slight to well-defined 5km reactions could be observed in test group animais. The second challenge with a 25% test substance preparation did not cause any skin reaction.

Based on the results of this study it was concluded that the test item does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.